The Role of Somatostatin in the Hemodynamics of the Hepatic Circulation in Patients Undergoing Liver Resection

NCT ID: NCT04010669

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-07-31

Brief Summary

The purpose of the present clinical trial is to study the effect of somatostatin in the regulation of velocity and blood flow of the hepatic circulation in patients undergoing liver resection. The patients will be randomized in two groups: the study group will receive somatostatin and the control group will receive the placebo. In both groups, patients will undergo hepatectomy and directly postoperatively they will receive either somatostatin or placebo, depending on their randomization. The primary endpoint will be the increase or decrease of the velocity and the flow of the hepatic circulation estimated by ultrasonography compared to the same parameters when measured preoperatively.

Detailed Description

The purpose of the present clinical trial is to study the effect of somatostatin in the regulation of blood flow of the portal circulation at patients who have undergone hepatectomy. The patients will be randomized in two groups, namely the group that will receive somatostatin (study group) and the group that will receive the placebo (control group). In both groups, patients will undergo liver resection and directly postoperatively they will receive either somatostatin (2 amps at 1000ml normal saline solution in continuous 24-hour infusion for 5 days) or a 24 hours infusion of 1000ml Normal Saline solution 0.9%. On the first, third, fifth and seventh postoperative day, the velocity and the diameter of the portal vein, splenic vein, hepatic artery and hepatic veins will be measured sonographically and the flow will be calculated using the following mathematic formula: Flow= velocity x cross section area (the cross section area of the vessel can be calculated using the following equation: cross section area=πr2, with 'r' representing the vessel's radius).

Preoperatively

On the day before the surgery (day -1),an ultrasound will be performed in order to measure the velocity and the diameter of the portal vein, splenic vein, hepatic artery and hepatic veins and the flow will be calculated using the following mathematic formula: Flow= velocity x cross section area, as stated above. The following data will also be recorded: platelets, bilirubin (total and direct), albumin, cholesterol, urea, International Normalized Ratio, sodium, Serum Glutamic Oxaloacetic Transaminase, Serum Glutamic Pyruvic Transaminase, Alkaline Phosphatase, gamma-Glutamyl Transferase and the Model for End-stage Liver Disease score of each patient will be calculated. Finally, our patients will undergo a Computer Tomography scan in order to measure their liver and spleen volumetry.

On the day of the surgery

On the day of the surgery (day 0), the following information will be recorded: the type of the surgical procedure, the duration (in minutes), the presence of ascites, the number of times and total duration of the a pringle maneuver and finally the percentage of the resection of the parenchyma will be calculated. A biopsy of healthy liver tissue will be sent for histological examination in order to determine the presence of fibrosis/cirrhosis and its stage.

Postoperatively

On the first, third and fifth postoperative day (day 1, 3, 5), the preoperative blood test and the ultrasound measurements will be repeated and the amount of fluid in the drain(s) and inside the abdomen (via ultrasound) will be recorded. Finally, the fluid will be sent for biochemical examination and culture.

On the seventh postoperative day (day 7) all blood, fluid and ultrasound measurements will be repeated and also the liver and spleen volumetry via CT.

Conditions

Portal Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Study group

The study group includes participants who will receive somatostatin postoperatively (after liver resection).

Group Type: ACTIVE_COMPARATOR

Somatostatin

Intervention Type: DRUG

2 amp of somatostatin at 1000ml normal saline solution in continuous 24-hour infusion for 5 days

Control group

The control group includes participants who will receive placebo (a 24 hours infusion of 1000ml Normal Saline solution 0.9%) postoperatively (after liver resection).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

24 hours infusion of 1000ml Normal Saline solution 0.9%

Interventions

Somatostatin

2 amp of somatostatin at 1000ml normal saline solution in continuous 24-hour infusion for 5 days

Intervention Type: DRUG

Placebo

24 hours infusion of 1000ml Normal Saline solution 0.9%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing hepatectomy for any reason including primary malignant liver tumors (hepatocellular carcinomas, cholangiocellular carcinomas, etc), metastatic liver disease and symptomatic benign liver lesions (liver adenomas, focal nodular hyperplasia, hemangiomas, etc).
• Adult patients (≥18 years old)
• Patients whose indication for hepatectomy will be decided by a multidisciplinary team meeting.
• Patients who eill agree to sign an informed consent

• Patients undergoing synchronous hepatectomy-colectomy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laikο General Hospital, Athens

OTHER

Sponsor Role: lead

Responsible Party

Kotsifa Evgenia

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios C Sotiropoulos, MD, PhD

Role: STUDY_CHAIR

Assistant Professor of Surgery, Laiko Hospital

Central Contacts

Evgenia C Kotsifa, MD

Role: CONTACT

eugeniakotsifa@yahoo.gr

00306986640874

Georgios C Sotiropoulos, MD, PhD

Role: CONTACT

gsotirop@yahoo.com

00306948111291

Other Identifiers

Somatostatin trial

Identifier Type: -

Identifier Source: org_study_id